Regeneron has taken a further swipe at Amgen after the biosimilars sponsor surprised the market by launching the first US rival to Eylea at-risk last month.
MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.
The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.
Having previously set itself a deadline of the end of November to strike a licensing deal for one of two biosimilar candidates – or risk failing to meet its working capital requirements – Sweden’s Xbrane has now announced a global licensing partnership with Intas for its nivolumab Opdivo rival, with just days to spare.
The latest campaign from Biosimilars Canada, #SaveBigWithBiosimilars, targets businesses to raise awareness of the benefits of using biosimilars for employee health benefit plans.
Dual filings for Formycon’s aflibercept biosimilar have delivered results, with the Eylea rival endorsed under two names by the EMA’s CHMP.
Samsung Bioepis may be only the second company to obtain an EMA positive opinion for a denosumab biosimilar, but plenty more rivals are on the way with filings of their own.
As Fresenius delivered its third-quarter results, the firm’s Fresenius Kabi division celebrated sales growth of two-thirds in its Biopharma biosimilars segment amid several solid increases seen in Q3.
The UK’s National Health Service is set to roll out Teva’s varenicline smoking-cessation daily tablet to “tens of thousands” of smokers in England.
Fresenius Kabi-controlled mAbxience has struck a deal with Servier’s Egis Pharmaceutical to commercialize two biosimilar candidates in multiple central and eastern European markets.
Buoyed by the success of its long-acting risperidone injectable, Teva is continuing to feel upbeat about the potential for its olanzapine LAI candidate, ahead of a full study safety readout anticipated in the first half of 2025.
Running from 11-14 November, the fifth annual Global Biosimilars Week awareness campaign has been launched by the IGBA, with the international off-patent association this year focusing on advancing access.
Meitheal has announced a licensing agreement with parent company Hong Kong King-Friend to add another three biosimilars to its pipeline for the US market.
Coherus BioSciences will have to weather the storm of supply interruptions for its sole biosimilar product, Udenyca, in the final quarter of 2024.
Biogen has struck another blow against European generic competitors to Tecfidera, after the European Patent Office upheld a dosage patent for the brand that runs until February 2028. Meanwhile, the firm reported flat biosimilars sales in the third quarter of 2024.
In the first earnings call since Amgen confirmed launch of the first US biosimilar to Regeneron’s near $6bn Eylea brand, the originator spoke of its confidence in defending its brand, while also touching on how supply issues for repackaged Avastin had impacted its operations.
Alvotech and Advanz have celebrated a worldwide first with the European Medicines Agency’s acceptance of an application for their partnered golimumab biosimilar rival to Simponi.
All eyes are on Eylea, after Amgen said last week that it would launch the first US biosimilar in the face of ongoing litigation. The California-based player has spoken of its prospects in the wet-AMD space, including a desire to chart its own path amid supply shortages for Avastin.
In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.
While Roche admits that an acceleration of biosimilar competition to its blockbuster IL-6 inhibitor Actemra/RoActemra is anticipated in the final three months of the year, the Swiss originator has been surprised by the lack of challenge to its franchise so far.